An open-label, multicenter, randomized, controlled adaptive study to evaluate the efficacy and safety of investigational therapeutics for the treatment of hospitalized patients with mild to moderate novel coronavirus disease (COVID-19) in Kinshasa, Democratic Republic of the Congo

Creppat Laboratories SAR0 个研究点目标入组 376 人开始时间: 2023年10月24日最近更新: 2023年11月6日

试验速览

Abstract results see attached file 44329_OtherUnpublishedResults.pdf (added 18/10/2023)

•1. Male or non-pregnant female adult =18 years of age at time of enrolment. Children > 12 years of age and pregnant women may be included if recommended by the DSMB
•2. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR at a Government approved lab. from nasopharyngeal or oropharyngeal swab, within 48 hours prior to screening
•3. No severe acute respiratory syndrome (SARS), that is, not using mechanical ventilation
•4. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures
•5. Understands and agrees to comply with planned study procedures
•6. Agrees to the collection of NP/OP swabs and venous blood per protocol
•7. Agrees to not be enrolled in another trial for the full duration of the study
•8. Creatinine = 110 umol/L, creatinine clearance rate (eGFR) = 60 ml / min / 1.73m2, AST and ALT = 40 IU/L

•1. Asymptomatic subjects
•2. Requiring mechanical ventilation
•3. Creatinine > 110 umol/L, eGFR < 60 ml / min / 1.73m2, ALT/AST > 2 × ULN or TBIL > 2 × ULN
•4. Pregnancy or breastfeeding
•5. Anticipated transfer to another hospital which is not a study site within 72 hours
•6. History of allergy to any investigational product ingredients
•7. Shortness of breath in resting position
•8. Known prolonged QT syndrome
•9. Use of concomitant medications that prolong the QT/QTc interval
•10. Subjects who have severe underlying diseases that affect survival including uncontrolled malignant tumor with multiple metastases that cannot be resected, blood diseases, dyscrasia, active bleeding and severe malnutrition
•11. Subjects who in the opinion of the investigators after assessing all relevant parameters are unsuitable for the study

发起方

Creppat Laboratories SAR